MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2005-04-12 for TESTPACK PLUS HCG-URINE 3C07-16 manufactured by Abbott Laboratories.
[20239799]
The account generated a negative testpack plus hcg urine result on a urine sample from a pt. It is unk whether the urine sample was a first morning or random sample. The result was questioned as the pt's previous test had been positive along with ultrasound results and other clinical indications. The sample was repeated using another pack from the same lot and the results were positive. There was no impact to pt mgmt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-2005-00001 |
| MDR Report Key | 592649 |
| Report Source | 01,05 |
| Date Received | 2005-04-12 |
| Date of Report | 2005-04-07 |
| Date Mfgr Received | 2005-03-16 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2005-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TESTPACK PLUS HCG-URINE |
| Generic Name | RAPID PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2005-04-12 |
| Model Number | NA |
| Catalog Number | 3C07-16 |
| Lot Number | 16311M100 |
| ID Number | NA |
| Device Expiration Date | 2005-09-21 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 582496 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | INTERSECTION US 41 & 22ND ST NORTH CHICAGO IL 60064 US |
| Baseline Brand Name | TESTPACK +PLUS HCG URINE |
| Baseline Generic Name | QUALITATIVE URINE PREGNANCY TEST |
| Baseline Model No | NA |
| Baseline Catalog No | 3C07-16 |
| Baseline ID | NA |
| Baseline Device Family | TESTPACK +2 URINE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 13 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954029 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-12 |